Actively Recruiting
Extended Therapy Versus Traditional Therapy With Letrozole for Ovulation Induction in Women With Polycystic Ovary Syndrome: A Randomized Controlled Trial
Led by GABRIEL MONTEIRO PINHEIRO · Updated on 2025-11-28
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of extended letrozole therapy compared with standard letrozole therapy for ovulation induction in women with polycystic ovary syndrome (PCOS). This randomized clinical trial involves 84 women aged 18 to 40 years diagnosed with PCOS. The study aims to determine if a longer duration of letrozole treatment improves ovulation and pregnancy outcomes, addressing ongoing questions about optimal therapy length for anovulatory infertility. Participants are assigned to one of two groups: the standard therapy group receives 5 mg of letrozole daily for 5 days (cycle days 2 to 6), while the extended therapy group takes 5 mg daily for 10 days (cycle days 2 to 12). Ovulation will be monitored by transvaginal ultrasound and confirmed by urinary LH testing or corpus luteum visualization to compare the effects of both regimens. Throughout the study, participants undergo ovulation monitoring and assessments of mature follicle number and size, clinical pregnancy rates, miscarriage rates, multiple pregnancies, and ovarian hyperstimulation syndrome incidence. The primary outcome is the ovulation rate within one treatment cycle, and secondary outcomes include pregnancy-related measures tracked up to 12 weeks. The study starts in September 2025 and ends in July 2026, with all procedures conducted under medical supervision.
CONDITIONS
Brief Title
Letrozole Extended vs Traditional Therapy for Ovulation Induction in Women With PCOS (PROLEx-PCOS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 40 years
- Body mass index (BMI) between 18.5 and 31 kg/m2
- Diagnosis of Polycystic Ovary Syndrome (PCOS) by Rotterdam criteria (at least two of: oligo/anovulation, clinical or biochemical hyperandrogenism, polycystic ovarian morphology on ultrasound)
- Active desire for pregnancy at enrollment
- Ability and willingness to provide written informed consent
You will not qualify if you...
- Age under 18 or over 40 years
- Confirmed bilateral tubal factor infertility
- Severe male factor infertility
- Premature ovarian insufficiency
- Uncontrolled hyperprolactinemia or thyroid dysfunction
- Congenital or acquired uterine malformations
- History of gynecologic or breast cancer
- Known allergy or contraindication to letrozole
- Severe uncontrolled systemic diseases (cardiovascular, renal, hepatic)
- Pregnancy or breastfeeding at screening
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks (one treatment cycle)
Participants receive letrozole therapy for ovulation induction either by the traditional 5-day regimen or an extended 10-day regimen. Ovulatory response will be monitored by transvaginal ultrasound and biochemical markers of ovulation.
Multiple visits for ovulation monitoring during one treatment cycle
Duration - Up to 12 weeks
Participants are followed for reproductive outcomes including clinical pregnancy, miscarriage, and safety up to 12 weeks after treatment initiation.
Visits as needed for pregnancy and safety assessments
Trial Site Locations
Total: 1 location
1
Health Complex Dr Wladimir Arruda
São Paulo, São Paulo, Brazil, 04829-310
Actively Recruiting
Research Team
K
Katherine Ann R Miller, Medical student
G
Gabriel M Pinheiro, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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